TARGIS SYSTEM
FDA premarket approval P970008/S027 · decided 2005-04-29
Approval details
- PMA number
- P970008
- Supplement
- S027
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TARGIS SYSTEM
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Applicant
- Urologix, LLC
- Date received
- 2005-04-07
- Decision date
- 2005-04-29
- Days to decision
- 22 days
- Decision code
- APPR
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- APPROVAL FOR UPGRADING A TARGIS CONTROL BOARD (LUXTRON SUB-ASSEMBLY).
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.